Zimmer Spine has announced the recall of a medical device that is used during spinal fusion surgery, as it has been determined that it may break inside of a patient’s body, causing internal injuries and blood loss. Ummm…wow, that can’t be good.
The Zimmer PEEK Ardis Inserter is used to implant the PEEK Ardis Interbody Spacer, a device used in posterior spinal fusion procedures. The inserters are being recalled because Zimmer Spine has received reports of PEEK Ardis Interbody Spacer implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery. Zimmer estimates from reports that the inserters appear to be breaking at a rate of about 0.52%, or one out of approximately every 200.
The recall affects all lots of the PEEK Ardis Inserter, including inserters in the Ardis Instrument Set with part number 3256-01 and Specialty Ardis Inserters with part numbers:
The part number and lot number are located on the inserters.
While there have been no post-operative complaints regarding the breakages, Zimmer warns that the fractured implants could cause dural tears and blood loss.
Surgeons and hospitals worldwide are being warned to immediately stop using the PEEK Ardis Inserter and return any in their inventory to Zimmer Spine. Unfortunately for Zimmer, this also means that the PEEK Ardis Interbody Spacer cannot be used either, since it cannot be implanted without the Inserter.
The recalled medical devices were distributed from June 2008 through December 2012. About half were distributed in the U.S. and the rest were sold around the world.
Patients with questions are encouraged to visit their website.